FDA applicant

Sisu Global Health

Baltimore, MD1 decision2021–20210 recalls

FDA records 1 decision for Sisu Global Health (Baltimore, MD) in 2021: 1 510(k) clearance. All are in product code CAC (Apparatus, Autotransfusion). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Sisu Global Health’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Sisu Global Health by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sisu Global Health

Which product codes does it file in?

What has FDA decided for it lately?